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RecruitingNCT06161285BRONCHOBIOTEUpdated Feb 26, 2025

Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants

An observational study in Bronchiolitis, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 3 sites in France. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2025-02-26.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
1 Day to 12 Months
Sex
All
01

Study summary

Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the importance of the microbiota (intestinal, oral or nasopharyngeal) and of the immune response to RSV in children, We will include 80 children under 2 years old with hospitalized bronchiolitis and non-hospitalized bronchiolitis. Oral, nasal and stool samples will be taken to study the various microbiota in search of dysbiosis. A capillary blood sample will be taken for immune studies.

02

Conditions studied

  • Bronchiolitis

Keywords

  • Newborns
  • Dysbiosis
  • respiratory syncytial virus (RSV)
03

In context

Bronchiolitis

365 studies on the registry are indexed under Bronchiolitis; 45 are open to participants now.

This study's planned enrollment of 120 is below the median of 192 across 95 observational studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Bronchiolitis in patient under 12 months old

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Infants \<12 months
  • With bronchiolitis during RSV epidemic season
  • No chronic illness
  • No bronchiolitis medical history
  • Signed consent from parents or legal guardians

Exclusion criteria

Exclusion Criteria:

  • Chronic respiratory illness
  • Medical history of bronchiolitis or newborn asthma
  • Treatment with immunosuppressants
  • Patient with no social security affiliation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Severe bronchiolitis

    venous blood samples. Buccal, nasopharyngeal and rectal swabs

    Other: Sampling

  • Non-hospitalized bronchiolitis

    Capillary blood samples. Buccal, nasopharyngeal and rectal swabs

    Other: Sampling

  • Bronchiolitis ihospitalized in ICU

    Capillary blood samples. Buccal, nasopharyngeal and rectal swabs

Interventions

  • OtherSampling

    Single-time sampling of respiratory virus-infected children

06

What researchers measure

Primary outcomes

  1. Dysbiosis

    comparison of the quantitative and qualitative composition of bacteria (alpha diversity, beta diversity, Shannon and Simpson index) in the digestive and nasopharyngeal microbiota

    Time frame: Inclusion

Secondary outcomes

  1. Measurement of innate and adaptive responses by quantification of cytokines and chemokines in plasma

    Inflammatory/regulatory cytokines (IL1-\>17, IL-10, TGF-b, EGF, FGF-2, IFN-alpha, IFN-gamma, IFN-beta, MCRP-1 MCP-3, TNF-alpha...), cytokines of adaptative response (Th1, Th17, Th2 and/or Treg), markers of inflammatory response (interferon, TNFa, …), quantified by Luminex

    Time frame: inclusion

  2. Identifying the mRNA profile in blood samples and nasal swabs

    mRNA will be identified by using RNA-Seq (Illumina)

    Time frame: inclusion

  3. Sequencing viral strains for mutation

    Typing of respiratory syncytial virus-A (RSV-A) and B (RSV-B) and sequencing of strains (Amplicons)

    Time frame: Inclusion

  4. Comparison of respiratory syncytial virus (RSV) antibodies levels on newborn screening specimen and on capillary swab during infection

    Levels of RSV antibodies will be measured and compared between newborn screening specimen and capillary swab during infection

    Time frame: Birth, Inclusion

  5. Study the load of Streptococcus pneumoniae (Sp) in RSV infections.

    Compare the serotypic profiles of pneumococcus (Sp) present during RSV infections

    Time frame: Inclusion

07

Study locations

3 of 3 sites recruiting
  • APHP, Antoine Béclère Hospital
    Clamart, 92140, France
    Recruiting
  • AP-HP,Raymond Poincaré Hospital
    Garches, 92380, France
    Recruiting
  • Réanimation médico-chirurgicale Necker
    Paris, 750, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06161285
Collaborators
Infectious Diseases Models for Innovative Therapies center
Responsible party
Sponsor
First posted
Dec 7, 2023
Start date
Dec 6, 2024
Primary completion
Mar 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Feb 26, 2025

Study contacts

Etienne BIZOT, Doctor
Contact
etienne.bizot@aphp.fr
33145374618
Etienne BIZOT, Doctor
principal investigator · AP-HP Hôpital Antoine Beclere

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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